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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over-The-Counter Hair Removal
510(k) Number K262524
Device Name Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
Applicant
ONE BEAUTY Technology Co., Ltd.
Rm. 2208, Shenye Center Bldg., 5045 Shennan E. Rd., Xinwei C
Shenzhen,  CN 518022
Applicant Contact Ninghua Pan
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90, Qianhai Rd.
Shenzhen,  CN 518082
Correspondent Contact Axiu Yang
Regulation Number878.4810
Classification Product Code
OHT  
Date Received07/22/2026
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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